Standard No.:	YY/T 1629.2-2018
English Name:	Cutting tools for electric osseous tissue surgical equipment—Part 2:Cranial perforator
Chinese Name:	电动骨组织手术设备刀具 第2部分：颅骨钻头
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.30 11.040.30    Surgical instruments and materials 11.040.30
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2018-11-07
Implemented on:	2019-11-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	160.0
Delivery:	via email in 1 business day

YY/T 1629.2-2018 Cutting tools for electric osseous tissue surgical equipment - Part 2: Cranial perforator 1 Scope This part of YY/T 1629 specifies the materials, requirements, test methods, instructions and labeling for cranial perforators among cutting tools for electric osseous tissue surgical equipment. This part is applicable to the cranial perforators (hereinafter referred to as products) with a function of mechanical clutch drilling and automatic stopping. The product is usually composed of inner drill, outer drill, clutch mechanism, coupling, etc. The cranial perforators of other working modes may be selected and adopted according to applicability. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies. GB/T 1220 Stainless steel bars GB/T 4340.1-2009 Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1: 2005, MOD) GB/T 6682 Water for analytical laboratory use - Specification and test methods GB/T 14233.1-2008 Test methods for infusion, transfusion, injection equipments for medical use - Part 1: Chemical analysis methods GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1: 2009, IDT) GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5: 2009, IDT) GB/T 16886.10-2017 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10: 2010, IDT) YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance (ISO 13402: 1995, MOD) YY/T 0294.1 Surgical instruments - Metallic materials - Part 1: Stainless steel YY/T 0752-2016 Electrical surgical equipment for osseous tissue Pharmacopoeia of the People's Republic of China (Edition 2015) 3 Terms and definitions For the purposes of this standard, the terms and definitions established in YY/T 0752-2016 as well as the followings apply. For the convenience of application, some terms and definitions specified in YY/T 0752-2016 are listed below. 3.1 cranial perforator cutting tool that is powered by handpiece to perform mechanical rotary motion for cranial perforation 3.2 handpiece component held by an operator and capable of driving the clamped surgical cutting tool to achieve surgical purposes, which may be integrated or split type; a split-type handpiece is composed of a (power) handle that can provide power to the handpiece head, a handpiece head that clamps the cutting tool, and/or a speed and direction change mechanism [YY/T 0752-2016, Definition 3.5] 3.3 inner drill part that is used for osseous tissue resection and perforation 3.4 outer drill part that is used for osseous tissue resection and bone pad forming 3.5 cutting part part of inner drill and outer drill that performs resection on osseous tissue, typically consisting of cutting edges

Contents Foreword i 1 Scope 2 Normative references 3 Terms and definitions 4 Materials 5 Requirements 6 Test methods 7 Instructions and labeling